AccessGUDID - DEVICE: ClarifEye Marker (00884838096844)

GUDID

Device Identifier (DI) Information

Brand Name: ClarifEye Marker
Version or Model: 45980159392x
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Philips DS North America LLC

Primary DI Number: 00884838096844
Issuing Agency: GS1
Commercial Distribution End Date: November 09, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 118983916 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66941	Radiological image marker, noninvasive, single-use	A non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker or clip, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZZ	Marker, Skin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33694bc7-e938-406c-a53c-6efc2861b5bf
Public Version Date: March 12, 2024
Public Version Number: 4
DI Record Publish Date: July 22, 2021